Antibiotics for at Risk CHildren with InfluEnza

The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (ARCHIE): a doubleblind randomised placebo-controlled trial ‘At risk’ children aged 6 months to 12 years inclusive who present in primary care with influenza/influenza like illness (ILI) and meet our trial eligibility criteria will be invited to join the study.  For each child entering the trial a healthcare professional will complete a baseline assessment and obtain two swabs: a nasal swab for detection of influenza by Polymerase Chain Reaction (PCR) and a throat swab for bacterial culture and sensitivity.

Participants will be randomised to receive either co-amoxiclav 400/57 or placebo, which will be taken orally twice daily for 5 days.  Parents/guardians of trial participants will be given a study diary in which to record doses of study medication given to the child, temperature, symptoms and adverse events. Parents/guardians will also be asked to record in their study diaries items relating to healthcare resource utilisation, parent or child burden.  

Objectives:

The primary objective of the trial is to determine whether early treatment with co-amoxiclav reduces the likelihood of re-consultation due to clinical deterioration in ‘at risk’ children with influenza/ILI.

Secondary objectives are:

• To determine whether early treatment with co-amoxiclav reduces duration of fever in ‘at risk’ children with influenza/ILI.

• To determine whether early treatment with co-amoxiclav reduces duration of symptoms in ‘at risk’ children with influenza/ILI.

• To compare further intervention rates in ‘at risk’ children with influenza/ILI treated with coamoxiclav versus placebo.

 • To compare adverse events in ‘at risk’ children with influenza/ILI treated with co-amoxiclav versus placebo.

• To develop and validate risk scores for influenza-related clinical deterioration and complications for use in children with influenza/ILI.

• To explore the cost-effectiveness of different potential strategies for early antibiotic use in ‘at risk’ children with influenza/ILI.

• To examine the impact on antibiotic resistance of early co-amoxiclav use in ‘at risk’ children with influenza/ILI.

• To determine the impact on long-term respiratory bacterial carriage of early co-amoxiclav use in ‘at risk’ children with influenza/ILI.

The ARCHIE trial will be led by Dr Kay Wang at the University of Oxford with support from Professor Alastair Hay at the University of Bristol, Dr Mike Moore and Professor Paul Little at Southampton University and Dr Calum Semple at Liverpool University.

 

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